Intraabdominal PressureNCT04929639
The Effect of Intrabdominal Pressure in Patients Undergoing Bariatric Surgery
An observational study of Intraabdominal Pressure and Bariatrik Surgery, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Morbid obesity is a global health problem that concerns the whole world. It is associated with many concomitant health problems such as diabetes, hypertension, congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Intraabdominal Pressure, Bariatrik Surgery
- What is being tested?
- measurment of intraabdominal surgery
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2020to 5 May 2021
- How long will I take part?
- 16 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)> 35, 18-60 years old, female, non-smoker
Who may be able to join
- ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)> 35, 18-60 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included
Who cannot join
- Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intrabdominal Pressure on Postoperative Mortality and Morbidity in Patients Undergoing Bariatric Surgery
Morbid obesity is a global health problem that concerns the whole world. It is associated with many concomitant health problems such as diabetes, hypertension, congestive heart failure. There are publications showing that morbid obesity increases chronic intra-abdominal pressure, and it has been investigated that this chronic pressure exposure may cause many comorbidities accompanying obesity. When we reviewed the literature, we could not find an adequate study showing the effects of obesity-related increased intra-abdominal pressure on postoperative mortality and morbidity.
The aim of this study is to show the effect of obesity-related intra-abdominal pressure on postoperative mortality and morbidity.
Read the detailed description
Our study included 80 female patients with ASA (American Society of Anesthesia) II-III, who were planned to undergo laparoscopic sleeve gasterctomy or bypass operation after ethics committee approval. BMI (body Mass Index)> 35, 18-65 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included. Propofol 2mg/kg, Remifentanil 1mcg/kg, and rocuronium 0.6mg/kg were administered to the patients by monitoring with ECG, pulse oximetry and non-invasive blood pressure measurement, which we performed in bariatric surgery patients in our clinic. The corrected weights of the patients were used in dose calculations as recommended by the Society of Bariatric Anesthesia. Immediately after intubation, while the patient was lying in the supine position, intra-abdominal measurement was taken from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation was placed by the general surgeon, another measurement was made from the trocar port. The measurements were recorded. Arterial blood pressure, heart rate, oxygen saturation, maintenance fluids, and complications were recorded every 5 minutes intraoperatively. Postoperative hospital stay of the patients, urine output, onset time of bowel movements, and all complications were recorded.
SPSS 21.0 computer program was used for statistical analysis. The normality of the distribution of the data was evaluated with the Kolmogorov-Smirnov test. Intergroup data will be evaluated by one-way ANOVA, and in-group data will be evaluated with repetitive ANOVA test. Chi-square was used in the analysis of ordinal data. P < 0.05 will be considered as a statistically significant difference. The sample size was calculated as 80 patients at 90% confidence interval.
- Conditions
- Intraabdominal Pressure, Bariatrik Surgery
- Being tested
- measurment of intraabdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurment of intraabdominal surgeryOther
Immediately after intubation, while the patient is lying in the supine position, an intra-abdominal measurement will be made from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation is placed by the general surgeon, another measurement will be made from the trocar port. Measurements will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of obesity-related intra-abdominal pressure
measure intra-abdominal pressure from the trochar site
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start5 Jan 2020
- Primary completion5 Jun 2020
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal PressureStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
- Investigators
- MELIHA ORHON ERGUN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929639
- Sponsor's protocol ID
- 09.2020.133
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrabdominal Pressure on Postoperative Mortality and Morbidity in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04929639
- Acronym / sponsor ID
- 09.2020.133
- Conditions
- Intraabdominal Pressure, Bariatrik Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Morbid obesity is a global health problem that concerns the whole world. It is associated with many concomitant health problems such as diabetes, hypertension, congestive heart failure. There are publications showing that morbid obesity increases chronic intra-abdominal pressure, and it has been investigated that this chronic pressure exposure may cause many comorbidities accompanying obesity. When we reviewed the literature, we could not find an adequate study showing the effects of obesity-related increased intra-abdominal pressure on postoperative mortality and morbidity.
The aim of this study is to show the effect of obesity-related intra-abdominal pressure on postoperative mortality and morbidity.
Detailed description
Our study included 80 female patients with ASA (American Society of Anesthesia) II-III, who were planned to undergo laparoscopic sleeve gasterctomy or bypass operation after ethics committee approval. BMI (body Mass Index)> 35, 18-65 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included. Propofol 2mg/kg, Remifentanil 1mcg/kg, and rocuronium 0.6mg/kg were administered to the patients by monitoring with ECG, pulse oximetry and non-invasive blood pressure measurement, which we performed in bariatric surgery patients in our clinic. The corrected weights of the patients were used in dose calculations as recommended by the Society of Bariatric Anesthesia. Immediately after intubation, while the patient was lying in the supine position, intra-abdominal measurement was taken from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation was placed by the general surgeon, another measurement was made from the trocar port. The measurements were recorded. Arterial blood pressure, heart rate, oxygen saturation, maintenance fluids, and complications were recorded every 5 minutes intraoperatively. Postoperative hospital stay of the patients, urine output, onset time of bowel movements, and all complications were recorded.
SPSS 21.0 computer program was used for statistical analysis. The normality of the distribution of the data was evaluated with the Kolmogorov-Smirnov test. Intergroup data will be evaluated by one-way ANOVA, and in-group data will be evaluated with repetitive ANOVA test. Chi-square was used in the analysis of ordinal data. P < 0.05 will be considered as a statistically significant difference. The sample size was calculated as 80 patients at 90% confidence interval.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 16 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)> 35, 18-60 years old, female, non-smoker
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)> 35, 18-60 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included
Key exclusion criteria (1 listed)
- Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurment of intraabdominal surgeryImmediately after intubation, while the patient is lying in the supine position, an intra-abdominal measurement will be made from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation is placed by the general surgeon, another measurement will be made from the trocar port. Measurements will be recorded. | Other | – |
Primary outcome
the effect of obesity-related intra-abdominal pressure
Time frame: during procedure
measure intra-abdominal pressure from the trochar site
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MELIHA ORHON ERGUN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Pressure and Bariatrik Surgery, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of obesity-related intra-abdominal pressure (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.